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Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery (SITACABG NonDM)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Sitagliptin
Placebo
Regular Human Insulin
Insulin glargine
Supplemental insulin (Insulin lispro)
Supplemental insulin (Insulin aspart)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Non diabetic hyperglycemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males or females between the ages of 18 and 80 years undergoing, cardiac surgery
  • No previous history of diabetes
  • No previous history of hyperglycemia

Exclusion Criteria:

  • Patients with hyperglycemia (blood glucose > 125 mg/dL); or glycated hemoglobin (HbA1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin
  • Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR < 30 mL/min) or clinically significant hepatic failure
  • Moribund patients and those at imminent risk of death (brain death or cardiac standstill)
  • Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction
  • Patients with clinically relevant pancreatic or gallbladder disease
  • Treatment with oral or injectable corticosteroid
  • Mental condition rendering the subject unable to understand the scope, and consequences of the study
  • Female subjects who are pregnant or breast feeding at time of enrollment into the study

Sites / Locations

  • Grady Health System
  • Emory University Hospital - Midtown
  • Emory University Hospital
  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sitagliptin

Placebo

Arm Description

Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.

Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.

Outcomes

Primary Outcome Measures

Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
Number of Subjects With Persistent Hyperglycemia
Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)

Secondary Outcome Measures

Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.
Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.
Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.
Duration of Continuous Intravenous Insulin (CII)
Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.
Mean Units Subcutaneous (SQ) Insulin Required
Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).
Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.
Total Insulin Therapy in the Intensive Care Unit (ICU)
Total amount of insulin glargine insulin (units) administered in the ICU per day.
Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.
Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Number of participants with blood glucose (BG) >180 after transition from ICU.
Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Number of participants with blood glucose (BG) <70 during ICU stay.
Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Number of participants with blood glucose (BG) <70 after transition from ICU.
Number of Participants With Blood Glucose Less Than 40 mg/dl
Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.
Hospital Mortality Rate
The total number of subject deaths during hospital stay will be recorded.
Intensive Care Unit (ICU) Mortality Rate
The total number of subject deaths during ICU stay will be recorded.
Number of Participants With Cerebrovascular Events
Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.
Hospital Complication Rate
The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.
Length of Stay: Intensive Care Unit (ICU)
Number of days in the ICU after coronary artery bypass graft surgery (CABG).
Length of Hospital Stay After Study Randomization
Number of days in the hospital after a participant is randomized to a study intervention.
Number of Participants Re-admitted to the Hospital Due to Wound Infections
Number of subjects readmitted to the hospital within 30 days due to wound infection.
Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.
Number of Participants With Emergency Room (ER) Visits
Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.
Number of Participants With Infections Not Requiring Hospital Re-admission
Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.
Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
The number of subjects requiring the use of inotropes for >24 hours post CABG.
Number of Subjects Requiring Re-intubation
The number of subjects requiring re-intubation after CABG.
Number of Subjects Requiring Re-intubation Within 24 Hours
The number of subjects requiring re-intubation with 24 after CABG.
Number of Subject Requiring Surgical Re-Intervention
The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.

Full Information

First Posted
May 11, 2015
Last Updated
January 8, 2018
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02443402
Brief Title
Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery
Acronym
SITACABG NonDM
Official Title
Sitagliptin for the Prevention and Treatment of Stress Hyperglycemia in Non-Diabetic Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare sitagliptin and placebo for the prevention of high blood glucose during surgery.
Detailed Description
About 80% of patients develop high glucose after cardiac surgery. High glucose is linked to an increased risk of hospital complications. High glucose increases the risk of wound infection, kidney failure and death. Patients with high glucose are treated with insulin given through an arm vein or by frequent insulin injections under the skin. This study will determine if sitagliptin can prevent the development of high glucose after heart surgery. Sitagliptin is a diabetes pill approved by the Food and Drug Administration (FDA) to treat patients with diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Non diabetic hyperglycemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sitagliptin
Arm Type
Experimental
Arm Description
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take sitagliptin. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive sitagliptin and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects undergoing cardiac surgery with no history of diabetes and with normal blood glucose (BG) will be randomized to take a placebo. Subjects with stress hyperglycemia (defined as a BG >180 mg/dL) in the intensive care unit (ICU) will continue to receive a placebo and will be started on continuous intravenous insulin (Regular Human Insulin) adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Additionally, once moved to the regular floors and out of ICU, the subjects can receive insulin glargine, insulin lispro, and/or insulin aspart depending on the blood glucose level.
Intervention Type
Drug
Intervention Name(s)
Sitagliptin
Other Intervention Name(s)
Januvia
Intervention Description
Subjects will take one pill daily until the day prior to them being discharged from the hospital. Sitagliptin will be dispensed orally at 100 mg/day and at a lower dose 50 mg for patients with glomerular filtration rate (GFR) < 30-50. If the calculated GFR drops to 30 mL/min/1.73m2 or below, patients will receive study medication 25mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One pill daily until discharge
Intervention Type
Drug
Intervention Name(s)
Regular Human Insulin
Other Intervention Name(s)
Novolin-R, Humulin-R
Intervention Description
Continuous intravenous insulin given to ICU patients with a BG > 180 mg/DL for two consecutive readings and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Intravenous insulin infusion will be continued until the patient is able to eat and/or transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Other Intervention Name(s)
Lantus (glargine)
Intervention Description
When regular insulin is discontinued, if needed, insulin glargine will be given once daily. Patients who required continuous insulin infusion at an average rate >2U/h will be transitioned to basal (to be given approx. 4 hours prior to discontinuing the insulin drip) starting at a dose 0.2 U/Kg/d. Subjects with a BG at 140-200 mg/dL will start glargine at 0.2 U/kg weight per day. And subjects with BG between 201-400 mg/dL will start glargine at 0.2 U/Kg/day The basal insulin dose will be adjusted as follow: If fasting and pre-dinner BG is between 100 - 180 mg/dL in the absence of hypoglycemia the previous day: no change If fasting and pre-dinner BG is between 180 - 240 mg/dL in the absence of hypoglycemia: increase glargine by 10% every day If fasting and pre-dinner BG is > 241 mg/dL in the absence of hypoglycemia the previous day: increase glargine dose by 20% every day If fasting and pre-dinner BG is < 100 mg/dL in the absence of hypoglycemia: stop glargine
Intervention Type
Drug
Intervention Name(s)
Supplemental insulin (Insulin lispro)
Other Intervention Name(s)
Humalog
Intervention Description
Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: BG between 181-220 mg/dL; 2-4 units of insulin lispro BG between 221-260 mg/dL; 3-5 units of insulin lispro BG between 261-300 mg/dL; 4-6 units of insulin lispro BG between 301-350 mg/dL; 5-7 units of insulin lispro BG between 351-400 mg/dL; 6-8 units of insulin lispro BG > 400 mg/dL; 7-9 units of insulin lispro
Intervention Type
Drug
Intervention Name(s)
Supplemental insulin (Insulin aspart)
Other Intervention Name(s)
Novolog
Intervention Description
Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows: BG between 181-220 mg/dL; 2-4 units of insulin aspart BG between 221-260 mg/dL; 3-5 units of insulin aspart BG between 261-300 mg/dL; 4-6 units of insulin aspart BG between 301-350 mg/dL; 5-7 units of insulin aspart BG between 351-400 mg/dL; 6-8 units of insulin aspart BG > 400 mg/dL; 7-9 units of insulin aspart
Primary Outcome Measure Information:
Title
Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)
Description
Number of participants who developed stress hyperglycemia (BG >180 mg/dl) during coronary artery bypass grafting (CABG) or after CABG requiring continuous IV insulin infusion (CII) while in the ICU.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Subjects With Persistent Hyperglycemia
Description
Number of subjects with persistent hyperglycemia (2 consecutive fasting and/or premeal BG > 180 mg/dL, or with average daily BG >180 mg/dl) who require insulin glargine (rescue therapy) after discontinuation of continuous intravenous insulin (CII)
Time Frame
Post-Surgery (Up to 10 Days)
Secondary Outcome Measure Information:
Title
Need for Continuous Intravenous Insulin (CII) for Treatment of Hyperglycemia
Description
Number of subjects with hyperglycemia (BG >180 mg/dL) who require CII in the ICU.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Mean Daily Intensive Care Unit (ICU) Blood Glucose (BG) Concentration
Description
The blood glucose levels will be assessed throughout the day using a glucose meter. An average will be calculated. The normal BG range for someone with diabetes is 80-130 mg/dL.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Mean Amount of Insulin Therapy in the Intensive Care Unit (ICU)
Description
The mean number of insulin infusions given per day (unit/day) while subjects are in the ICU. The more insulin given, the more hyperglycemic events experienced.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Duration of Continuous Intravenous Insulin (CII)
Description
Mean number of hours on continuous intravenous insulin (CII) after ICU discharge.
Time Frame
Post-Intensive Care Unit (ICU) Discharge (Up to 4 Days)
Title
Mean Units Subcutaneous (SQ) Insulin Required
Description
Mean number of supplemental insulin units (lispro or aspart) administered after receiving insulin glargine (SQ insulin).
Time Frame
Post-Surgery (Up to 10 Days)
Title
Mean Blood Glucose (BG) Concentration After Transition From Intensive Care Unit (ICU)
Description
The blood glucose levels will be assessed throughout the day using a glucose meter after transition form the ICU. The normal BG range for someone with diabetes is 80-130 mg/dL.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Total Insulin Therapy in the Intensive Care Unit (ICU)
Description
Total amount of insulin glargine insulin (units) administered in the ICU per day.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Participants With Severe Hyperglycemic Events During Continuous Insulin Infusion (CII)
Description
Number of participants with two consecutive blood glucose concentrations >180 mg/dL in ICU during CII.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Participants With Hyperglycemia After Transition From Intensive Care Unit (ICU)
Description
Number of participants with blood glucose (BG) >180 after transition from ICU.
Time Frame
Post-Surgery (Up to 10 Days)
Title
Number of Participants With Hypoglycemia During Intensive Care Unit (ICU) Stay
Description
Number of participants with blood glucose (BG) <70 during ICU stay.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Participants With Hypoglycemia After Transition From Intensive Care Unit (ICU)
Description
Number of participants with blood glucose (BG) <70 after transition from ICU.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Participants With Blood Glucose Less Than 40 mg/dl
Description
Number of participants with blood glucose (BG) <40 throughout the duration of hospitalization.
Time Frame
Duration of Hospitalization (Up to 30 Days)
Title
Hospital Mortality Rate
Description
The total number of subject deaths during hospital stay will be recorded.
Time Frame
Post-Surgery (Up to 10 Days)
Title
Intensive Care Unit (ICU) Mortality Rate
Description
The total number of subject deaths during ICU stay will be recorded.
Time Frame
Post-Surgery (Up to 4 Days)
Title
Number of Participants With Cerebrovascular Events
Description
Number of participants that experienced permanent stroke and reversible ischemic neurologic deficit events.
Time Frame
Post-Hospital Discharge (Up to 10 Days)
Title
Hospital Complication Rate
Description
The total number of all complications experienced during hospitalization. Participants may experience more than one complication during hospitalization and these will be included in the hospital complication rate.
Time Frame
Duration of Hospitalization (Up to 30 days)
Title
Length of Stay: Intensive Care Unit (ICU)
Description
Number of days in the ICU after coronary artery bypass graft surgery (CABG).
Time Frame
Post-Surgery (Up to 4 Days)
Title
Length of Hospital Stay After Study Randomization
Description
Number of days in the hospital after a participant is randomized to a study intervention.
Time Frame
Post-Randomization (Up to 9 days)
Title
Number of Participants Re-admitted to the Hospital Due to Wound Infections
Description
Number of subjects readmitted to the hospital within 30 days due to wound infection.
Time Frame
Post-Hospital Discharge (Up to 30 Days)
Title
Number of Participants Re-admitted to the Hospital Not Due to Wound Infections
Description
Number of subjects readmitted to the hospital within 30 days for all causes excluding wound infection.
Time Frame
Post-Hospital Discharge (Up to 30 Days)
Title
Number of Participants With Emergency Room (ER) Visits
Description
Number of subjects returning to the ER up to 30 days (all-cause) after hospital discharge.
Time Frame
Post-Hospital Discharge (Up to 30 Days)
Title
Number of Participants With Infections Not Requiring Hospital Re-admission
Description
Number of subjects with infections not requiring hospital re-admission within 30 days after hospital discharge.
Time Frame
Post-Hospital Discharge (Up to 30 Days)
Title
Number of Subjects Requiring the Use of Inotropes for Greater Than 24 Hours
Description
The number of subjects requiring the use of inotropes for >24 hours post CABG.
Time Frame
Post-Surgery (Up to 2 Days)
Title
Number of Subjects Requiring Re-intubation
Description
The number of subjects requiring re-intubation after CABG.
Time Frame
Post-Surgery (Up to 2 Days)
Title
Number of Subjects Requiring Re-intubation Within 24 Hours
Description
The number of subjects requiring re-intubation with 24 after CABG.
Time Frame
Post-Surgery (Up to 24 Hours)
Title
Number of Subject Requiring Surgical Re-Intervention
Description
The number of subjects that require surgical re-intervention due to mediastinal exploration and post-operative hemorrhage.
Time Frame
Post-Surgery (Up to 10 Days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females between the ages of 18 and 80 years undergoing, cardiac surgery No previous history of diabetes No previous history of hyperglycemia Exclusion Criteria: Patients with hyperglycemia (blood glucose > 125 mg/dL); or glycated hemoglobin (HbA1c) > 6.5%; or previous treatment with oral antidiabetic agents or insulin Severely impaired renal function (serum creatinine ≥3.0 mg/dL or GFR < 30 mL/min) or clinically significant hepatic failure Moribund patients and those at imminent risk of death (brain death or cardiac standstill) Subjects with gastrointestinal (GI) obstruction or adynamic ileus or those expected to require GI suction Patients with clinically relevant pancreatic or gallbladder disease Treatment with oral or injectable corticosteroid Mental condition rendering the subject unable to understand the scope, and consequences of the study Female subjects who are pregnant or breast feeding at time of enrollment into the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Umpierrez, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Emory University Hospital - Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States

12. IPD Sharing Statement

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Sitagliptin in Non-Diabetic Patients Undergoing Cardiac Surgery

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